Mechanical Ventilation Clinical Trial
— GEMINIOfficial title:
Assessment of Clinical Practice of Mechanical Ventilation After COVID-19 Pan-demic Among 57 Countries: A Systematic Analysis for the Global BurdEn of Me-chanIcal VeNtilatIon (GEMINI Study) 2022, From VENTILAGROUP.
BACKGROUND: Changes in the clinical practice of mechanical ventilation during and after the coronavirus pandemic (COVID-19) worldwide could influence the clinical outcomes of critically ill patients with mechanical ventilation due to a generalization of these changes. Thus, the variability of the clinical response of different strategies in critically ill patients could be related to the existence of unidentified phenotypes that would be related to an increased risk of mortality and functional deterioration at the medium term. OBJECTIVES: The main objective will be to evaluate the worldwide clinical practice of mechanical Ventilation in critically ill patients, as well as the medium-term clinical outcomes for the description of phenotypes of critically ill patients treated with mechanical ventilation. The analysis of phenotypes and unsupervised pattern recognition over time could help to predict relevant clinical outcomes. This approach could improve personalized and precision medicine applicable to the ventilated patient. METHODOLOGY: An observational, prospective, non-interventional, international, and multicenter study will be carried out that will include adult critically ill patients requiring invasive or non-invasive mechanical ventilation for more than 12 hours. Analyzes of the variability of mortality and functional impairment at six months will be performed. Likewise, artificial intelligence analyzes ("machine learning" and "neural networks") will be carried out.
Status | Recruiting |
Enrollment | 10900 |
Est. completion date | September 30, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 119 Years |
Eligibility | Inclusion Criteria: - All consecutive adult patients (= 18 years old) who are admitted to the ICU and require invasive mechanical ventilation (endotracheal tube or tracheostomy) longer than 12 hours. 2. Adult patients admitted to the ICU and require advanced respiratory support (high flow oxygen nasal cannula [HFONC], or noninvasive ventilation [NIV] BIPAP or CPAP with oronasal, nasal, helmet or facial mask) with acute respiratory failure defined as PaO2/ fraction of inspired oxygen (FiO2), [PaO2/FiO2] ratio <300, or the pulse oximetric saturation (SpO2/FiO2 ) ratio < 315 for more than 1 hour. 3. Adult patients in whom mechanical ventilation were started outside the study ICU at the same Institution and/or a different Institution, including Emergency Room, Operating Room (OR), /or were then transferred to the ICU at the participating center Exclusion Criteria: - The following ICUs will be excluded: 1. Pediatric ICU. 2. Post-Operators Anesthesia Recovery Room. 2. Patients less than 18 years old. 3. Patients admitted after elective surgery and who require mechanical ventilation for less than 12 hours (excepting patients who receive non-invasive ventilation). 4. Patients will be excluded if they were transferred to participating ICUs without a documented intubation time, or underwent a tracheotomy at prior to ICU admission. 5. Patients that were at participating ICUs for 24 hours or more, were readmitted during the study period |
Country | Name | City | State |
---|---|---|---|
Spain | Intensive Care Unit, Hospital Universitario de Getafe | Getafe | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Getafe | Spanish Research Center for Respiratory Diseases |
Spain,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ICU mortality | rate of dead patients requiring mechanical ventilation during ICU stay | From date of inclusion until the date of death from any cause during ICU stay, whichever came first, assessed up to 6 weeks | |
Secondary | hospital mortality. | rate of dead patients requiring mechanical ventilation during hospital stay | From date of inclusion until the date of death from any cause during hospital stay, whichever came first, assessed up to 6 months | |
Secondary | duration of mechanical ventilation. | length of invasive ventilatory support | from orotracheal intubation date until scheduled extubation date or 24 hours of unassisted respiratory support in tracheotomized patietns | |
Secondary | 28-day mortality. | rate of dead patients requiring mechanical ventilation until 28-day hospital stay | from initiacion from mechanical ventilation until 28-day hospital stay. | |
Secondary | 6 months mortality | rate of dead patients requiring 3 days of mechanical ventilation after hospital discharge | from hospital discharge date until 6 months of follow-up in surviors from ICU stay. | |
Secondary | 6-months frailty. | assessment of clinical frailty scale at 6-months after hospital discharge. | from hospital discharge date until 6 months of follow-up in surviors from ICU stay, assessed by Clinical Frailty Scale (CFS, where values between 1-9 points, a higher scores mean a worse outcome) | |
Secondary | reintubation. | rate of failed extubated patients following 48 hours from scheduled extubation | From date of orotracheal scheduled extubation until the date of reintubation from any cause during ICU stay, assessed up to 48 hours | |
Secondary | ICU stay. | length of ICU stay. | From date of inclusion (ICU admission) until the date of ICU discharge, assessed up to 6 weeks, including survivors and nonsurvivors from ICU | |
Secondary | hospital stay. | length of hospital stay. | From date of inclusion (ICU admission) until the date of hospital discharge, assessed up to 6 monthss including survivors and nonsurvivors from ICU | |
Secondary | ICU free days. | It will defined the ICU-free days as 30 minus the number of days in the ICU (range, 0-30 days). For patients who survived and were in the ICU for less than 30 days, the ICU-free day's outcome measure was obtained by subtracting the length of the ICU stay from 30 | events during ICU stay (from ICU admission to ICU discharge dates) | |
Secondary | ventilator-free days (VFD). | VFD will be defined as follows:
VFDs = 0 if subject dies within 28 days of mechanical ventilation. VFDs = 28 - x if successfully liberated from ventilation x days after initiation. VFDs = 0 if the subject is mechanically ventilated for >28 days |
events during ICU stay (from ICU admission to ICU discharge dates) From date of orotracheal intubation until the date of unassisted positive pressure ventilation, either without orotracheal tube or tracheal cannula, assessed up to 6 months | |
Secondary | tracheotomy rate. | rate of tracheotomized patients in those patients receiving invasive mechanical ventilation | events during ICU stay (rate of performance for scheduled tracheotomy, assessed up to 6 months) | |
Secondary | decision for withdrawal or withholding vital support rate. | rate of those patients that will have a decision for withdrawal or withholding vital support rate during ICU stay | events during ICU admission through study completion, an average of 6 months. |
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